This paper outlines the application of human performance principles to document design and provides guidance for how to implement this in a biopharmaceutical manufacturing environment, with proven results. A more effective system for creating and revising documents—specifically, one that is
aligned with human performance principles—leads to reduced time spent revising documents, improved training and performance, and fewer deviations and CAPAs. By investing the time to understand how work is done and creating documents that align with the needs of the end-user and the realities of how work is performed, we can harness the reliability and promise of a learning organization that is steeped in the principles of human performance.
Operations
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Continued process verification (CPV) and the validation of informatics systems
Nov 2018 | Continued process verification, Drug Substance, Fill Finish, POI - Drug Substance
Continued process verification (CPV) provides ongoing verification of the performance of a manufacturing process and as such entails the processing of large amounts of data. This paper draws on the experiences of multiple biopharmaceutical manufacturing companies in validating the informatics components of their CPV programs. It sheds light on common issues and provides recommendations and best practices. Computer systems validation is relevant across the lifecycle of a CPV informatics solution. As such the papers scope includes the initial and ongoing activities and deliverables to determine that the solution meets its intended uses and other requirements, for example, data integrity and performance requirements.Â
Human performance (HuP): Guide to implementing and maintaining a leader observation and coaching program
Oct 2018 | Drug Substance, Fill Finish, POI - Drug Substance
A well established Human Performance program will significantly reduce failures and deviations in any biomanufacturer’s operation. Critical to this is the creation of a culture where leaders partner with workers to learn about what enables success and what creates challenges. This learning is most effectively done through first-hand observation, active listening and ensuring candid discussions about systems’ issues related to risk. Written by BioPhorum’s Human Performance Workstream, this guide details how to implement and maintain a leader observation and coaching program, what such a program entails, the expected benefits, the expectations for leaders and a suggested implementation plan.
Human performance (HuP): A new measurement approach to better drive, safety, quality, reliability in biopharmaceuticals
Aug 2018 | Drug Substance, Fill Finish, POI - Drug Substance
One of the dilemmas companies face when driving down failures and near misses to ‘zero’ is what to measure. Conventional approaches often fail to support ambitious ‘zero’ performance levels and can discourage the right type of debates and discussions. This guide from the Human Performance (HuP) team explains how biopharma operations can understand and measure performance in the most meaningful way and how to capture risks and enable sustainable learning and improvement through the ‘Family II’ mindset. Piloted by four companies the guide explains how to measure success rates and encourage employee reporting, how to implement such reports, and management the communication around the program to help everyone get closer to the target of zero failures.
Continued process verification (CPV) of legacy products in the biopharmaceutical industry
Jun 2018 | Continued process verification, CPV, Drug Substance, POI - Drug Substance, Publication
This guide to the implementation of continued process verification (CPV) across a portfolio of legacy products complements the foundational document ‘Continued process verification (CPV): An industry position paper with an example plan’ published in 2014. The guide helps biomanufacturers understand how to build efficient and effective plans for legacy products and links to QA systems, provides guidance on implementations across multiple sites and advises on discovery, disclosure and regulatory reporting.
Human performance (HuP): Training for biotech manufacturing operator competence
Mar 2016 | Drug Substance, Fill Finish, POI - Drug Substance
For decades, the biopharmaceutical industry has trained its workforce with a ‘read and understand’ approach. This approach is outdated and ineffective at delivering effective learning and competent staff. This ‘Training for competence’ guidance enables companies to understand how their organisation compares to their peers, and to identify what ‘best in class’ looks like for operator training, and will help to identify how to implement this approach across their networks
Human performance (HuP): Changing the performance paradigm in pharma/biotech: Integrating human performance in global organizations
Sep 2015 | Drug Substance, Fill Finish, POI - Drug Substance
In 2015 when the BioPhorum Human Performance team started to understand how the industry could reduce error rates many were seeing a plateau of performance. Industry data showed 50% of deviations were attributable to human error and that the error rate has been constant over several years. Comparing us to other high-risk industries with unparalleled levels of reliability, such as nuclear power and aviation, the team saw that changes that could be made with the integration of HuP into our operations.
This article utilizes the experience of two large, global biotech companies, at the time to illustrate the pathways to integrate HuP and the benefits realized not just in human error reduction, but also to quality, safety, compliance, and on-time delivery—the critical measures that will make or break a biotech company’s performance.
